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Apellis' (APLS) Blood Disorder Drug Gets FDA's Priority Tag
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Apellis Pharmaceuticals, Inc. (APLS - Free Report) announced that the FDA has accepted the new drug application (NDA) for its lead pipeline candidate, pegcetacoplan, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and granted Priority Review designation. The FDA has set an action date of May 14, 2021, and stated that it does not currently intend to hold an advisory committee meeting to discuss the application. PNH is a rare, chronic, life-threatening blood disorder.
The Priority Review designation from the FDA is generally granted to drugs that would bring significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
The NDA submission was supported by results from the phase III PEGASUS study. The PEGASUS study met its primary endpoint of improvement in hemoglobin levels and pegcetacoplan showed its superiority to Alexion Pharmaceuticals’ Soliris. The candidate also demonstrated non-inferiority to Soliris on two other metrics, including the number of individuals who were transfusion-free. Hence, the positive results from the study showed that pegcetacoplan has the potential to become a new standard of care for PNH.
Shares of the company have increased 25.5% year to date compared with the industry’s growth of 1.5%.
In September 2020, Apellis submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for pegcetacoplan, for the treatment of PNH in the European Union. The EMA validated the MAA in October 2020 and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in 2021.
Pegcetacoplan is a promising candidate being developed for subcutaneous administration in several indications. Two phase III studies (DERBY and OAKS) evaluating pegcetacoplan in patients with geographic atrophy in age-related macular (GA) are ongoing and the company expects to announce data from these studies in the third quarter of 2021.
Pegcetacoplan is also being evaluated in phase II studies for the treatment of cold agglutinin disease (CAD). The company is also evaluating the candidate in phase II studies to treat four types of glomerular diseases— C3 glomerulopathy (C3G), IgA nephropathy, primary membranous nephropathy and lupus nephritis.
ASLAN’slossper share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days. Shares of the company have increased 90.4% year to date.
Alimera’sloss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days. Shares of the company have increased 11.9% year to date.
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Apellis' (APLS) Blood Disorder Drug Gets FDA's Priority Tag
Apellis Pharmaceuticals, Inc. (APLS - Free Report) announced that the FDA has accepted the new drug application (NDA) for its lead pipeline candidate, pegcetacoplan, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and granted Priority Review designation. The FDA has set an action date of May 14, 2021, and stated that it does not currently intend to hold an advisory committee meeting to discuss the application. PNH is a rare, chronic, life-threatening blood disorder.
The Priority Review designation from the FDA is generally granted to drugs that would bring significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
The NDA submission was supported by results from the phase III PEGASUS study. The PEGASUS study met its primary endpoint of improvement in hemoglobin levels and pegcetacoplan showed its superiority to Alexion Pharmaceuticals’ Soliris. The candidate also demonstrated non-inferiority to Soliris on two other metrics, including the number of individuals who were transfusion-free. Hence, the positive results from the study showed that pegcetacoplan has the potential to become a new standard of care for PNH.
Shares of the company have increased 25.5% year to date compared with the industry’s growth of 1.5%.
In September 2020, Apellis submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for pegcetacoplan, for the treatment of PNH in the European Union. The EMA validated the MAA in October 2020 and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in 2021.
Pegcetacoplan is a promising candidate being developed for subcutaneous administration in several indications. Two phase III studies (DERBY and OAKS) evaluating pegcetacoplan in patients with geographic atrophy in age-related macular (GA) are ongoing and the company expects to announce data from these studies in the third quarter of 2021.
Pegcetacoplan is also being evaluated in phase II studies for the treatment of cold agglutinin disease (CAD). The company is also evaluating the candidate in phase II studies to treat four types of glomerular diseases— C3 glomerulopathy (C3G), IgA nephropathy, primary membranous nephropathy and lupus nephritis.
Zacks Rank &Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include ASLAN Pharmaceuticals Ltd. (ASLN - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
ASLAN’slossper share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days. Shares of the company have increased 90.4% year to date.
Alimera’sloss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days. Shares of the company have increased 11.9% year to date.
Apellis Pharmaceuticals, Inc. Price
Apellis Pharmaceuticals, Inc. price | Apellis Pharmaceuticals, Inc. Quote
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